Protocol summary

Study aim
This study will be performed to compare the pharmacokinetics and invivo parameters of Ciprofloxacin 500 mg tablet formulation as a test product with Ciprobay 500 mg formulation as a reference product and to evaluate the bioequivalence of these two formulations.
Design
Non blinded, randomized, crossover in vivo bioequivalence study in 24 healthy male under fasting condition.
Settings and conduct
In each period, volunteers will receive a single dose intervention (1 or 2) in the Noor Research & Educational Institute (Tarasht, Tehran).16 blood samples were collected during 24hours post intervention. A 7-day washout interval separated to study periods.
Participants/Inclusion and exclusion criteria
Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range between 18.5 - 30 kg/m2. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Previous history of allergy to a fluoroquinolone or severe allergic reaction to any medication. History of CNS disorders (e.g. convulsive seizures). History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neuromuscular, psychiatric, auto-immune or neurological disorders.
Intervention groups
Intervention group 1: Ciprofloxacin 500 mg tablet , produced by Cosar pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product. Intervention group 2: Ciprobay 500 mg tablet , produced by BAYER is the reference product. In each period, 12 of 24 subjects will be given a single oral dose of this product.
Main outcome variables
Peak Plasma Concentration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180620040164N62
Registration date: 2024-06-08, 1403/03/19
Registration timing: prospective

Last update: 2024-06-08, 1403/03/19
Update count: 0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Soheil Famili
Name of organization / entity
Noor research and educational institute (Tavan)
Country
Iran (Islamic Republic of)
Phone
+98 21 6600 7026
Email address
info@tavaninstitute.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-08-05, 1403/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of Ciprofloxacine 500 mg Tablet of Cosar Pharmaceutical Co. and Ciprobay 500 mg tablet of BAYER as reference in 24 healthy male under fasting.
Public title
Comparative in vivo evaluation of 2 Ciprofloxacine 500 mg Tablet formulations.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subjects (male) between 18 – 50 years of age and Body Mass Index (BMI) within 15% of normal range between 18.5 - 30 kg/m2. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. ubjects that have normal vital signs. Subjects who agree with patient consent form.
Exclusion criteria:
Previous history of allergy to a fluoroquinolone or severe allergic reaction to any medication. History of CNS disorders (e.g. convulsive seizures). History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neuromuscular, psychiatric, auto-immune or neurological disorders. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period. Heavy drinker of caffeine, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity. A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.
Age
From 18 years old to 50 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization schedule will be generated with https://www.sealedenvelope.com/simple-randomiser/v1/lists. A 2*2 block randomization list is created. We have 12 blocks and within each two volunteer's number (allocated after screening) for all 24 volunteers. According to this list, a treatment sequence of Test/Reference or Reference/Test will be given to each volunteer.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of Medica
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2024-05-27, 1403/03/07
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1403.035

Health conditions studied

1

Description of health condition studied
Bacterial infections
ICD-10 code
A49.8
ICD-10 code description
Other bacterial infections of unspecified site

Primary outcomes

1

Description
Peak Plasma Concentration (Cmax)
Timepoint
16 blood samples will be withdrawn pre-dose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4.5, 6, 8, 12 and 24 hours after intervention.
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)

Secondary outcomes

1

Description
AUC (Area Under the Concentration-Time Curve)
Timepoint
16 blood samples will be withdrawn pre-dose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4.5, 6, 8, 12 and 24 hours after intervention.
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)

Intervention groups

1

Description
Intervention group 1: Ciprofloxacine 500 mg Tablet, produced by Cosar Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wash-out period the intervention 2 will be given to these subjects.
Category
Treatment - Drugs

2

Description
Intervention group 2: Ciprobay 500 mg tablet, produced by BAYER is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wash-out period the intervention 1 will be given to these subjects.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Noor Research & Development Institut(Tavan)
Full name of responsible person
Behzad Motaha Sangari
Street address
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
City
Tehran
Province
Tehran
Postal code
4635314588
Phone
+98 21 6600 4027
Email
info@tavaninstitute.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Cosar Pharmaceutical Co.
Full name of responsible person
Dr. Babak Mesbahi
Street address
Darougar street, 17km Old Way Karaj-Tehran.
City
Tehran
Province
Tehran
Postal code
1415519871
Phone
+98 21 4492 1074
Email
info@cosarpharm.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cosar Pharmaceutical Co.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Noor Research & Development Institute
Full name of responsible person
Behzad Montaha Sangari
Position
CEO(Chef Executive Officer)
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
info@tavaninstitute.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tavan Institute
Full name of responsible person
Seyed Mohsen Foroutan
Position
Principal investigator
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
mforoutan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tavan Institute
Full name of responsible person
Behzad Montaha Sangari
Position
CEO(Chef executive officer)
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
Behzad_first@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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